Liability of Medical Devices: A Look at IP rights and liability in the midst of a health crisis

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By Beatrice Mungai

In early April, Kenyatta University announced that they had developed prototype ventilators to assist in the emergency response for COVID-19.[1] Since then several other prototypes have been rolled out. At the end of April, Kenya Association of Manufactures also made public a prototype they had locally developed,[2] and in early May, Jomo Kenyatta University of Agriculture and Technology team of engineers unveiled two portable solar-powered ventilators.[3] These ventilators have offered some hope that Kenya stands a chance in curbing the shortage of ventilators, which are crucial for coronavirus patients.

Such efforts to develop ventilator locally are commonplace in most countries across the globe. As coronavirus has tested the strength of many public health systems, local companies and manufacturers have teamed up to try and meet the gap left by a global shortage of ventilators.[4] As the country grapples with this crisis, it will be important that the prototypes being rolled out do not cause more harm than good. This post looks at the intersection of intellectual property rights and product liability in light of the need for rapid response, against maintaining safety standards.

Determining liability for medical devices

Product liability is used to determine or place fault for any goods or services whose use or application causes injury to the user. It can be established through 3 ways: the tort of negligence for the breach of a duty of care, under the Consumer Protection laws on product liability and in Contract law. Under the tort of negligence, the claimant needs to show that the defendant owes them a duty of care justifying an award of compensation for injuries caused by or resulting from the latter’s negligence in making the product. Using this, the claimant can sue the manufacturer and other parties in the supply chain if fault can be established in the product.[5]

Under the consumer protection laws, the manufacturer of the finished products or a component thereof, the supplier of a natural product and other persons in the commercial chain of preparation or distribution of a product have liability over the product.[6] In contract, it is possible for the seller to exclude themselves from liability, but this is governed strictly. For instance a manufacturer cannot exclude guarantees that are statutorily required. This is especially common in commercial contracts involving sale of goods.

Torts and consumer protection law is the most appropriate avenues for actions relating to product liability involving the public. Contracts law, being a private arrangement, binds the parties only and third-party claims are difficult to prove. Under tort and consumer protection, liability attaches to manufacturers by default and may extend to any third party who took part in the process between production and consumption such as suppliers.  

Intellectual Property Rights and Product Liability

Intellectual Property Rights play a big role in the innovation process of medical devices. They give the owner title and rights to enable them earn from their inventions. When it comes to product liability, the IP rights relating to the product could be indicative of where fault lies or its extent, in case of defects in the invention. Whereas cases in which an inventor is sued are rare, it is possible to have them as co-defendants. Inventors are hardly found individually liable because they mostly develop goods during the course of their employment, thus their inventions being belong to their employer. In cases of independent inventors, they could license or transfer the invention IP rights to manufacturers with capacity to produce en masse. It is therefore not a surprise that in most product liability cases it is the parties closer to the consumer who are sued i.e. the distributors and the manufacturers, often corporate entities. However, they can be held liable if the product is found defective from the original design.[7]

Additionally, there have been studies carried out on the effects of enforcement of product liability laws. These studies show that whereas product liability lawsuits reveal important information on safety, they tend to discourage innovation.[8] Innovation is as necessary to society as product safety, therefore there has been efforts to strike a balance between the two.

In American courts, inventors have been found liable for negligence where their creation causes injuries to a consumer but the strict liability imposed by consumer protection laws did not apply in their case.[9] The precedence has been that the intellectual property owner should have no liability for injuries caused by a licensee or assignee if they (IP owner) had no input into, or knowledge of the nature, development, testing or manufacturing of the end product. [10]The person’s participation in creating the end product therefore is seen as a measure of contribution warranting them to be held liable. The IPR owner is not held liable for injury caused by an end product that made use of their invention if they were not involved or had substantial input in the development of said product.

Ensuring compliance with Product Safety rules during COVID.

There are various regulatory agencies charged with ensuring that products are safe for consumer use in Kenya. For medical devices, the Kenya Bureau of Standard (KEBS) and the Pharmacy and Poison’s Board (PPB) work jointly to ensure the safety of medical devices. They carry out this function using the Guideline for inspection of imported medical devices, food supplements, medical cosmetics, herbal products and other borderline products, and other borderline products.[11] The legal regime that governs the safety of medical devices consists of: the Health Act 2017[12], the Health Products and Technologies (Medical Devices including IVD Medical Devices) Regulations and the Guidelines on Submission of Documentation for Registration of Medical Devices. This regulatory regime ensures the safety of all medical equipment in the country.

However, for the COVID period, The Ministry of Health has formed an ad hoc committee with the mandate to review the prototypes to ensure their safety before use.    The Committee comprises of a nurse, and anaesthesiologist and a member each from KEBS and the PPB. [13]


[1] http://www.ku.ac.ke/ku/item/1656-ku-developes-prototype-ventilator-to-support-fight-on-covid-19

[2] https://www.nation.co.ke/news/Kenya-to-begin-mass-producing-ventilators-/1056-5530834-39evrn/index.html

[3]https://www.nation.co.ke/news/education/Covid-19-Jkuat-unveils-ventilator-contact-tracing-app/2643604-5545312-7afsvhz/index.html

[4] https://www.nation.co.ke/news/Countries-in-a-panic-over-ventilators/1056-5509484-bovjbp/index.html

[5]https://uk.practicallaw.thomsonreuters.com/3-500-9763?transitionType=Default&contextData=(sc.Default)&firstPage=true&bhcp=1

[6] Section 63 and 64 of the Competition Act.

[7] W.R. Norris, Tort Liability That May Attach to Intellectual Property Licensing, 13 J. Marshall L. Rev. 105 (1979)

[8] Steven Gaber, Economic Effects of Product Liability and Other Litigation Involving the Safety and Effectiveness of Pharmaceuticals, (RAND Corporation, 2004). See also, WK Viscusi, MJ Moore, ‘Product Liability, Research and Development, and Innovation’, (1993) 101 Journal of Political Economy 161.

[9] Buss, Melissa Evans (2000) “Products Liability and Intellectual Property Licensors,” William Mitchell Law Review: Vol. 27: Iss. 1, Article 28.

[10] WA Dreier, ‘A Question for Liability: Who’s to Blame when Products Developed by Licensees Cause Unforeseen…?’ < https://norrismclaughlin.com/articles/a-question-of-liability-whos-to-blame-when-products-developed-by-licensees-cause-unforeseen/ > accessed 5 June 2020

[11] https://kebs.org/index.php?option=com_content&view=article&id=207&catid=26&Itemid=178

[12] Sections 62 – 66 of the Health Act, 2017.

[13] https://www.nation.co.ke/dailynation/news/kenyans-to-wait-longer-for-production-of-local-ventilators-308310

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